Dispensing & Incompatibilities Flashcards
Small scale of production
Preparation, mixing, assembling, packaging or labeling of a drug
or device
COMPOUNDING
Large scale production
Production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from
substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or
repackaging of the substance(s) or labeling or relabeling of its
container, and the promotion and marketing of such drugs or devices
MANUFACTURING
to refer to compounded prescriptions
PREPARATION
refer to manufactured pharmaceuticals
PRODUCTS
ne that the pharmacist is not expecting to receive nor expecting to receive again
ISOLATED PRESCRIPTION
→ one that the pharmacist may expect to receive in the future on
a routine basis, and there may be some benefit to products quality to standardize preparations like this (Preparation
protocols on file)
ROUTINE PRESCRIPTION
one of which multiple identical units are prepared as a single
operation in anticipation of a receipt of prescription
BATCH PREPARED PRESCRIPTION
Factors to Consider in Compounding (7)
Stability
Compounding support
Training and experience of pharmacist
Equipment
Environmental/compounding facility
Formulas
Chemical supplies
extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that is possessed at the time of compounding
STABILITY
is the time and date after which the
compounded product should not be stored nor transported
beyond-use date
is the term for manufactured
products (date assigned)
Expiration date
For non-sterile compounded drug product packaged in tight,
light, resistant containers and stored at controlled room
temperature:
For non-aqueous liquids and solid formulations (manufactured drug product is the source of active
ingredient)
The beyond-use date is _____
The beyond-use date is not later than 25%
of the time remaining until the product’s expiration
date or 6 months, whichever is earlier
For product with A USP or NF substance as the
source of active ingredients → The beyond-use date is _____
The beyond-use date ≤ 6 months
For water-containing formulations (prepared from ingredients in solid form) → The beyond-use date is ____
The beyond-use date is not later than 14 days when stored at cold temp
For all other formulations → The beyond-use date is ______
The beyond-use date is not later than intended duration of therapy or 30 days, whichever is earlier unless there is a supporting valid scientific
stability information applicable to the specific prep
<795> BUD
A non-aqueous formulation (eg, a
capsule without water in it)
6 months maximum BUD
<795> BUD
An oral formulation containing water
14 days under refrigeration maximum BUD
<795> BUD
A topical containing water (eg, ointment)
30 days maximum BUD
(Usually if it contains water, it is
shorter beyond-use date because
of possible microbial contamination)
*Storage Temp
Freezer
between -25C and -10C
*Storage Temp
Cold Temp
not exceeding 8C
*Storage Temp
Refrigerator
thermostatically controlled between 2 and 8C
*Storage Temp
Cool Temp
between 8 and 15C
*Storage Temp
Controlled Room Temp
thermostatically controlled between 20C and 25C with allowed excursions between 15C to 30C
Based on the type and extent of the services one chooses to
provide
EQUIPMENT
[EQUIPMENT]
- for aseptic compounding of sterile solutions
- used to maintain the number of the particulates flowing in the
air
LAMINAR FLOW HOOD
- to maintain temperatures as specified in the USP
REFRIGERATOR
-instrument for determining the relative weights of substances
- should be selected correctly for the specific task at hand
- used skillfully
- protected from damage
- checked periodically
BALANCE
Classification of Balance (4)
Single-beam (equal/unequal arm)
Compound lever
Torsion
Electronic
-used to weigh up to 60 grams of the ingredient depending on the stated capacity
- all prescription departments, like in a hospital pharmacy must have
CLASS A OR CLASS III PRESCRIPTION
BALANCES
other balances may be used aside from Class A, provided they
give equivalent or better accuracy – like __________
electronic single-pan balance
Prescription balance uses the _____ or _____ principle
taut wire frame or
torsion principle
-a class III balance
- have a maximum maintenance
sensitivity of 6 mg with no load
and with full load, used to weigh
quantities up to 60g
PRESCRIPTION BALANCES
-typically this are the type of balances that have the sensitivity of less than 10mg.
-Most accurate compared to class III balance
ELECTRONIC BALANCES
-maximum weight that can be placed on the balance pan
CAPACITY
-or sensitivity requirement or sensitivity reciprocal ; the smallest weight that gives a
perceptible change in the indicating element
SENSITIVITY
In ______ the smallest weight increment that can be read on the digital display of
the balance (eg. 0.001 g)
ELECTRONIC BALANCE
On _______, the smallest weight
increment determined by the value of a hash-mark on the graduated dial or weigh beam
DOUBLE-PAN BALANCE
(Double-pan balance)
on the graduated dial or weigh beam (eg. on metric
scale of the dial, each mark = ____)
0.01g
- reproducibility of the weighing measurement as expressed by a standard deviation
PRECISION
closeness of the displayed weight as measured by the balance, to the true weight
ACCURACY
(SR) = mg
Sensitivity Requirement
The United States Pharmacopoeia, allow a max error of _____ on a single way operation
5%
- very handy and the securely contain substances being weighed
- useful for weighing liquids because they have rigid sides
- more expensive than weighing papers
WEIGHING DISH
Weighing dish is usually made of ______________, with capacity of _____mL
aluminum or polystyrene plastic
5 to 250mL
[Weighing Paper]
preferred and recommended
Glassine Paper
[Weighing Paper]
-more acceptable for most purposes
PARCHEMENT PAPER
[Weighing Paper]
-transparent and water-proof
WAX PAPER
[Weighing Paper]
-usually used for dry powder
SIMPLE BOND PAPER
[Weighing Paper]
- has surface that does not absorb materials placed on them
- drugs and chemicals are easily slipped off for
GLASSINE PAPER
[Weighing Paper]
- more absorbent than glassine and should not
be used for weighing thick liquids like coal tar
PARCHMENT PAPER
Stainless spatulas with ______ or ____ handles
wooden or plastic
Micro Spatulas aka
Small double bladed, nickel stainless steel spatulas
Hard Rubber aka
Teflon-coated stainless-steel spatulas
Flexible rubber spatulas aka
Rubber policeman or Rubber scrapers
Graduates such as cylindrical and conical; pipettes; and medicine dropper
used to measure solvents
Volumetric devices
- to contain that holds particular volume but will not dispense the exact volume (e.g. burettes and beakers)
TC
- to deliver that dispense the volume indicated;
designed to drain by gravity (e.g. pipettes)
TD
are the easiest to use with wide mouths, and bases are the easiest to clean. Liquids may be stirred in them with the aid of a stirring rod
Conical graduates
- as the diameter of the graduate increases, the _______ decreases
accuracy of
the measurement
- plastic or glass, with different capacities and different stern lengths and diameters
FUNNELS
used for transferring solutions from one
container to another and not used for thick emulsions or suspensions
- used for filtering solutions
FUNNELS WITH NARROW STEM DIAMETERS
- used for transferring powder from mortars and
other mixing vessels - may also be used for transferring emulsions or suspensions
FUNNELS WITH SHORT LARGER DIAMETER
STEMS OR POWDER FUNNELS
-ideal for particle size reduction and making
emulsions
- it should not be used for drugs that stain, drugs present in small quantity, and very potent or hazardous drugs
WEDGWOOD MORTARS
- have more attractive white glazed surface
- provide less shearing efficiency than wedgwood and are less durable
PORCELAIN MORTARS
similar to wedgwood mortars but have abradant interior working surfaces and have similar uses and precautions
- less durable than wedgwood mortars
CERAMIC MORTARS
- commonly used in hospitals
- have smooth, non-porous interior surfaces
- useful for drugs that stain
- useful for making solutions and for diluting creams
to lotions
GLASS MORTARS
- preferred for triturating highly potent drugs and to
triturate hazardous drugs - effective as Wedgewood or ceramic mortars in
reducing particle size of powder especially hard
crystals but not efficient for making emulsions and
suspensions
GLASS MORTARS
ANY ingredient for use in compounding a drug product
COMPONENT
- are chemicals, substances or other components of articles
intended for use in the diagnosis, cure, mitigation, treatment or prevention of diseases
ACTIVE INGREDIENT
- “Excipients” or “Pharmaceutic aids”
- inert ingredients or inactive ingredients
ADJUVANT
[GRADE]
Highest purity and required for accurate
volumetric analysis
Primary standard
[GRADE]
Very high purity (2)
Spectroscopic Grade
Analytical Reagent
[GRADE]
High purity; Conforms to minimum standards set by the American Chemical Society
ACS
[GRADE]
Meets minimum purity standards: conforms to tolerance set by the USP/NF
USP/NF
[GRADE]
Refined, but still of unknown quality
CP
[GRADE]
Undetermined quality
Technical or commercial
[GRADE]
Certified to meet or exceed the specification prescribed in the food
chemical codex
Unofficial FCC
[GRADE]
Chemicals that have clearance for use in the food
Food Grade
[GRADE]
For cosmetic purposes
Cosmetic grade
- imparts pleasant flavor and often odor to a preparation
FLAVORANT
[Flavoring Methodology]
blend different flavors; most common; appropriate for sour taste
BLENDING
[Flavoring Methodology]
- these are flavors with longer and stronger taste that are added to the obvious taste
OVERSHADOW
[Flavoring Methodology]
- formation of insoluble compounds of the
offending drug
PHYSICAL
[Flavoring Methodology]
- chemical reaction, such as adsorption
or complexation
CHEMICAL
[Flavoring Methodology]
- anesthetizing the taste buds
PHYSIOLOGICAL
Bitter Taste (2)
Chocolate
Anise
Sweet (3)
Fruit
Berry
Vanilla
Sour (4)
Citrus
Root Beer
Anise
Strawberry
Salty (5)
Butterscotch
Maple
Peach
Melon
Raspberry
App. Flavoring Methodology for medication with Sour taste (1)
Blending of Flavor
App. Flavoring Methodology for mdications with bitter taste
Blending
Physiological
Physical
[SOLVENT]
universal solvent, can dissolve both ionic and
polar solutes
WATER
[SOLVENT]
most commonly used as flavoring agents; easily driven off from the solution and easily salted out by electrolytes
AROMATIC WATER
[SOLVENT]
- solvent, flavorant, used as medicinals
SYRUP
[SOLVENT]
- best solvent for phenols, iodine, boric acid, borates, tannic acid and cresol
GLYCERIN
[SOLVENT]
- good solvent for organic compounds such as alkaloids, glycosides, camphor, phenol, tannins, balsams
resins and for some inorganic salts
ALCOHOL
[SOLVENT]
- not preferred for salts because it accentuates
the saline tastE
ELIXIRS
Aromatic elixir, NF contains approx. ____ alcohol
22%
[Oils]
solvents used for IM injection
Peanut, Corn, Sesame, Mineral (PMSC)
used as base for alkaloids
OLEIC ACID
for sprays and drops
OLIVE OIL
[Pharmaceutical Ingredient]
- agents that increase the thickness or hardness of
the preparation
STIFFENING AGENT
[Pharmaceutical Ingredient]
vehicle for drug substances formulated into suppositories
SUPPOSITORY BASE
